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RegisterUS (or EU) ANDA: Fail f2 but pass BE? [Regulatives / Guidelines]
Hi all,
A question, has anyone ever filed an ANDA with great BE study results (90% Cmax and AUC ~ 98-100%, adequate sample size, ISCV~25%) but with f2 << 50 (F2=30 due to differences in very early timepts) in the comparative dissolution study based on method recommended in the BE guidance for IR product?
1) F2 is not really applicable for IR, correct? The sampling timepts were 5, 10 ,20, 30, 45mins. I know that f2 is not really relevant if % dissolve > 85% in 15 mins, but my product is >85% after 20 mins..
2) is f2 based on guidance recommendation even relevant if the BE results are so good?
Thx
john
A question, has anyone ever filed an ANDA with great BE study results (90% Cmax and AUC ~ 98-100%, adequate sample size, ISCV~25%) but with f2 << 50 (F2=30 due to differences in very early timepts) in the comparative dissolution study based on method recommended in the BE guidance for IR product?
1) F2 is not really applicable for IR, correct? The sampling timepts were 5, 10 ,20, 30, 45mins. I know that f2 is not really relevant if % dissolve > 85% in 15 mins, but my product is >85% after 20 mins..
2) is f2 based on guidance recommendation even relevant if the BE results are so good?
Thx
john
Complete thread:
- US (or EU) ANDA: Fail f2 but pass BE?jag009 2022-09-01 22:16 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- US (or EU) ANDA: Fail f2 but pass BE? wienui 2022-09-01 23:22
- US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-02 00:29
- US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-02 11:37
- US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-04 23:13
- US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-05 11:16
- US (or EU) ANDA: Fail f2 but pass BE? wienui 2022-09-05 23:29
- US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-06 00:49
- US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-08 19:32
- US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-09 17:56
- US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-15 11:09
- US (or EU) ANDA: Fail f2 but pass BE? Rayhope 2022-09-15 15:13
- US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-20 16:02
- US (or EU) ANDA: Fail f2 but pass BE? Rayhope 2022-09-15 15:13
- US (or EU) ANDA: Fail f2 but pass BE? wienui 2022-09-05 23:29
- US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-05 11:16
- US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-04 23:13
- US (or EU) ANDA: Fail f2 but pass BE? dshah 2022-09-02 11:37
- US (or EU) ANDA: Fail f2 but pass BE? jag009 2022-09-02 00:29
- US (or EU) ANDA: Fail f2 but pass BE? wienui 2022-09-01 23:22
Ing. Helmut Schütz